JP2011501198A - Multi-chamber tissue storage system for molecular and tissue diagnostics - Google Patents

Abstract

  A container for storing a biological sample is disclosed. The container comprises a first chamber having a side wall extending between an open end and a closed end defining an interior of the first chamber configured to receive a sample holder. The container also includes a second chamber having sidewalls extending between the open end and the closed end and defining a second chamber interior configured to subsequently receive the sample holder. The interior of the second chamber is fluidly insulated from the interior of the first chamber. The removable closure is a portion of the open end of the first chamber and the open end of the second chamber while the sample holder is disposed within one of the first chamber interior and the second chamber interior. Enclose at least one of A first fluid may be disposed within the first chamber and a second different fluid may be disposed within the second chamber.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a US Provisional Patent Application No. 60 / 982,062, filed Oct. 23, 2007, the disclosure of which is incorporated herein by reference in its entirety. It claims the priority of “Chambered Tissue Continent System For Molecular and History Diagnostics”.

  The present invention relates to a container for storing a biological sample. More specifically, the present invention stores biological tissue specimens in one reagent or, if desired to do so, for a molecular or diagnostic test and / or histological test. It relates to a container for.

  Biological samples are often collected for the purpose of diagnostic evaluation by researchers or clinicians to determine the presence of a particular disease and to determine the appropriate treatment for the disease. Tissue samples are often taken from patients for molecular diagnostics and nucleic acid analysis, especially RNA and DNA analysis, now common in many disease treatment studies. A prerequisite for accurate RNA and RNA analysis is the presence of good quality, intact RNA and DNA in the biological sample.

  Often, histological or cytological analysis is performed immediately after taking a sample from a patient or source to avoid molecular changes that may occur during storage. These changes, such as gene transcription, result from degradation of nucleic acids in the sample caused by exposure of the untreated sample to some environmental stress. However, analysis of a sample immediately after it is taken is often impossible or impractical. Therefore, it is necessary to implement a system for storing samples under controlled conditions over a period of time while maintaining the structural and molecular integrity of the sample.

  Traditionally, one way to achieve such storage is by immersing the sample in a single fixed reagent. A typical fixing reagent is 10% formalin, but can include water, mixed alcohols, ethanol / acetone mixtures, and ethanol / acetic acid mixtures. Containers used for such storage generally consist of a single integrated cavity capable of containing an effective amount of a reagent for processing a specific biological tissue sample. A biological tissue sample is placed in a container together with a reagent, the container is closed, and then the sample is stored and transported while being stored with a fixed reagent. An example of such a container can be found in US Pat. While such containers have had some success in the industry, there are some limitations.

US Pat. No. 7,147,826 US Pat. No. 4,220,252 US Pat. No. 4,034,884

  According to one embodiment of the present invention, a container assembly for storing a biological sample extends between an open end and a closed end that extends between a first end and a second end. A container is provided comprising a first chamber having a sidewall defining an interior of the first chamber that is present and configured to receive a sample holder. The container also includes a second chamber having sidewalls extending between the open end and the closed end and defining a second chamber interior configured to subsequently receive the sample holder. The interior of the second chamber is fluidly insulated from the interior of the first chamber. The container surrounds at least one of the open end of the first chamber and the open end of the second chamber while the sample holder is disposed in one of the first chamber and the second chamber. And a removable closure for engaging the first end of the container.

  In one configuration, the sample holder is detachably connected to the closure. In other configurations, the sample holder is rotatable with respect to the closure. A platform can optionally be attached to the closure and configured to accommodate the sample holder. The platform may be rotatable with respect to the closure.

  The sample holder can comprise a closable housing that defines an internal cavity for holding a biological sample. The housing can include a plurality of fluid openings configured to allow fluid disposed within at least one of the first chamber interior and the second chamber interior to be within the interior cavity. In other configurations, the sample holder is a tissue cassette.

  The closure and the container can be fitted so that they can be screwed together. Optionally, the closure comprises a seal that is engageable with a circumference of at least one of the open end of the first chamber and the open end of the second chamber and forms a liquid impervious seal by this engagement. Can do. The container can define a longitudinal axis, the first chamber can be disposed on a first side of the longitudinal axis, and the second chamber can be on an opposite second side of the longitudinal axis. It can be arranged. The side walls of the first chamber and the second chamber can be joined to define the outer side wall of the container. In other configurations, the container has a first end and a second end, and the closure engages the first end of the container, and the open end of the first chamber and the second end Surround the open end of the chamber.

  The container may also include a visual indicator for distinguishing the first chamber from the second chamber. The visual indicator may be a label that is selectively positioned on the outer surface of the container. Alternatively, the visual indicator can be formed with a portion of the container. The visual indicator can be integrated with the container at a location adjacent to at least one of the open end of the first chamber and the open end of the second chamber. Where appropriate, the visual indicator is an alphanumeric representation.

  The interior of the first chamber of the container may have a first intended fill volume and the interior of the second chamber of the container may have a second intended fill volume. The second intended fill volume may be different from the first intended fill volume. The container can also include a first fluid disposed within the first chamber and a second fluid disposed within the second chamber. The first fluid may be different from the second fluid. In other configurations, the container may include a fluid disposed within the first chamber having a first concentration and a fluid disposed within the second chamber having a second concentration. it can. The first concentration may be different from the second concentration.

  The closure of the container may be a membrane surrounding at least one of the open end of the first chamber and the open end of the second chamber. Alternatively, the container can comprise both a closure and a membrane surrounding at least one of the open end of the first chamber and the open end of the second chamber. The membrane can be partially removable or puncturable.

  According to another embodiment of the present invention, a container for storing a biological sample has a first end, a second end, and a first end and a second end that define a container interior. And a side wall extending therebetween. The container also includes a first chamber defined within the container interior and having an opening adjacent the first end of the container. The container further comprises a second chamber defined within the container interior having an opening adjacent to the first end of the container. The second chamber is fluidly insulated from the first chamber. The container also includes a closure for sealing engagement with the first end of the container and a sample holder for storing the biological sample therein. The closure engages the container in a first direction in which the sample holder is received in the first chamber and in a second direction in which the same sample holder is subsequently received in the second chamber. Configured to do.

  In other configurations, the sample holder is rotatable with respect to the closure. The sample holder can comprise a closable housing that defines an internal cavity for holding a biological sample. The housing can include a plurality of fluid openings configured to allow fluid disposed in at least one of the first chamber and the second chamber to enter the internal cavity. In one particular configuration, the sample holder is a tissue cassette.

  The closure may include a seal that is engageable with a circumference of at least one of the opening of the first chamber and the opening of the second chamber and that forms a liquid-impermeable seal by this engagement. . In yet other configurations, the container may include a visual indicator for distinguishing the first chamber from the second chamber. The visual indicator may be a label that is selectively positioned on the outer surface of the container. The visual indicator can also be formed with a portion of the container.

  Optionally, the container can include a first fluid disposed within the first chamber and a second fluid disposed within the second chamber. The first fluid may be different from the second fluid. Alternatively, the container can include a fluid disposed in a first chamber having a first concentration and a fluid disposed in a second chamber having a second concentration. The first concentration may be different from the second concentration. The container can also include a membrane surrounding at least one of the opening of the first chamber and the opening of the second chamber.

  According to yet another embodiment of the present invention, a method for containing a biological sample includes a container having a first chamber having a side wall extending between an open end and a closed end defining an interior of the first chamber. Forming a step. The interior of the first chamber includes a first fluid disposed therein. The container also includes a second chamber having a side wall extending between an open end and a closed end defining an interior of the second chamber. The interior of the second chamber includes a second fluid disposed therein. The first fluid is different from the second fluid and the interior of the second chamber is fluidly insulated from the interior of the first chamber. The method also includes inserting the sample holder into the first chamber interior. The method further includes the step of subsequently transferring the sample holder into the interior of the second chamber.

  Optionally, the method includes a closure wherein the sample holder is detachably connected while the sample holder is disposed within at least one of the first chamber interior and the second chamber interior. The method further includes engaging the portion with a part of the container so as to be screwable.

  In another embodiment, a support assembly is provided for supporting a sample holder configured to receive a biological sample therein. The support assembly has a frame configured to receive the sample holder therein, the frame including the structure for engaging the sample holder and supporting the sample holder in the frame. Is provided. The support assembly also includes a platform connected to and supporting the receiving member, the platform engaging the container such that the sample holder received in the receiving member extends into the interior of the container. It is configured. The platform is preferably in a first position such that the sample holder housed in the housing member extends into the first interior of the container and the sample holder housed in the housing member. It is configured to engage the container in a second position such that it extends into the second interior of the container. The frame can comprise at least one opening configured to allow fluid to flow through the frame and to contact a sample holder supported by the frame. Furthermore, the platform desirably extends transversely to the receiving member.

  Desirably, the accommodating member accommodates the sample holder therein so that it can be opened. Further, the receiving member can comprise at least one finger that engages the sample holder to support the sample holder within the frame of the receiving member. Such fingers are configured to apply a biasing force to the sample holder to maintain and support the sample holder within the frame of the receiving member. In some embodiments, the receiving member of the support assembly can include a plurality of fingers for engaging the sample holder, at least one of the fingers being a sample relative to the frame of the receiving member. A biasing force is applied to the sample holder to maintain and support the holder. In this way, the plurality of fingers are configured to maintain and support a plurality of sample holders of various sizes and shapes relative to the frame of the receiving member.

  In still other embodiments, a closure assembly is formed for surrounding the container, the closure assembly comprising a support assembly as described above. In such a closure assembly, the platform interconnects the receiving member to the closure assembly. The platform is preferably rotatably supported on the closure assembly, and the closure assembly is threadably engageable with the container so that the operation of screwing the closure onto the container is performed. Can be achieved while the platform is maintained in a designated position within the container.

  Another embodiment contemplates a sample holder receiving member with a generally planar frame with a plurality of confinement surfaces, where the confinement surfaces are not tapered at the tapered end of the sample holder and the sample holder. The end can be confined. The member further comprises at least one and preferably a plurality of cantilever fingers extending from the frame, the cantilever fingers being engaged when the sample holder is engaged in the containment plane. It can be deflected from a low stress state to a high stress state, thereby maintaining the sample holder in the frame of the receiving member. At least one of the confinement surfaces can be a confinement latch that is deflectable to receive an edge of the sample holder, such as a tapered end of the sample holder.

  In another embodiment of the invention, the assembly comprises a sample holder in the form of a tissue cassette with a cavity that can be selectively surrounded by a door, the tissue cassette further comprising a tapered end and a non-tapered end. Prepare. The assembly further comprises a receiving member for removably receiving the sample holder, the receiving member comprising at least one deflectable surface extending from the base frame of the receiving member, wherein the at least one deflectable surface is When the sample holder is positioned in the receiving member, the sample holder is temporarily positioned with respect to the receiving member. The sample holder door can open relative to the cavity while the sample holder is positioned in the receiving member.

  Other details and advantages of the present invention will become apparent upon reading the following detailed description in conjunction with the accompanying drawings, in which like parts are designated with like reference numerals throughout.

1 is a perspective view of a container for storing a biological tissue sample according to an embodiment of the present invention. It is a disassembled perspective view of the container of FIG. It is a perspective view of the container housing of the container of FIG. FIG. 3 is a perspective view of one embodiment of a sample holder, shown in an open position. FIG. 4B is a perspective view of the sample holder of FIG. 4A shown in a closed position. It is a perspective view of the bottom part of the closure part of Drawing 1 to which a sample holder is attached. FIG. 6 is a cross-sectional view of the container taken along line 6-6 of FIG. 1 shown without a sample holder. FIG. 7 is a cross-sectional view of the container taken along line 7-7 of FIG. 1 shown without a sample holder. FIG. 2 is a partially exploded perspective view of the container of FIG. 1 shown with a sample holder inserted into the first chamber. It is a perspective view of the container by other one Embodiment of this invention. FIG. 10 is a side view of the container of FIG. 9 shown with a closure on top of the container. FIG. 6 is a top view of a container according to another embodiment of the present invention having an alphanumeric identification symbol. This is also a top view of a container according to yet another embodiment of the invention having an alphanumeric identifier. FIG. 6 is a perspective view of a container housing according to another embodiment of the present invention having a structural identification symbol. FIG. 12B is a top view of the container housing of FIG. 12A. FIG. 6 is a front view of a container according to another embodiment of the present invention, wherein the bottom end of the first chamber is integral with the bottom end of the second chamber. FIG. 6 is a front view of a container according to another embodiment of the present invention in which a closure is disposed between the open end of the first chamber and the open end of the second chamber. FIG. 6 is a perspective view of one embodiment of a containment element for use in connection with the present invention. FIG. 15B is a front view of the receiving element of FIG. 15A. FIG. 15C is a side cross-sectional view of the receiving element taken along line 15C-15C of FIG. FIG. 15B is a side view of the receiving element of FIG. 15A. FIG. 15B is a top view of the receiving element of FIG. 15A. FIG. 3 is a partial schematic cross-sectional view of a container according to an embodiment of the present invention having a portion of a closure and a platform molded accordingly. FIG. 16B is a partially exploded perspective view of the container of FIG. 16A. 1 is a perspective view of a container according to an embodiment of the present invention that is labeled with an identification symbol. FIG. FIG. 18 is an alternative perspective view of the container of FIG. 17. FIG. 6 is a partial schematic cross-sectional view of a container according to another embodiment of the present invention showing a perimeter seal. FIG. 19B is an enlarged view of FIG. 19A showing the peripheral seal in detail. FIG. 19B is a cross-sectional view of FIG. 19B showing a perimeter seal.

  For purposes of the following description, where spatial orientation terms are used, the terms are oriented in the accompanying drawings or otherwise described in the detailed description below. It shall be relevant to the embodiment referred to when. However, it should be understood that the embodiments described hereinafter may envision many alternative variations and embodiments. It is also to be understood that the specific devices illustrated in the accompanying drawings and described herein are exemplary only and should not be considered limiting.

  The container of the present invention can store biological samples such as tissue samples for molecular and tissue diagnostics, and in particular for histopathology studies. In particular, the container includes an open end and a closed end, and the interior of the container includes a first chamber and a second chamber that are fluidly insulated from each other. Accordingly, the liquid medium can be stored in at least one of these chambers, such as the second chamber. In this way, for example, a tissue sample contained in a first chamber can be handled or processed before the tissue is contacted with the solution in the second chamber. As described in further detail herein, in one embodiment of the present invention, the first chamber may be empty and a storage chamber, and the second chamber may include histopathology. A liquid medium such as a reagent in the form of a tissue fixing solution for fixing the sample for diagnosis can be placed. In this way, the tissue sample can be placed in the first chamber and, if necessary, the sample can then be transferred to the second chamber to bring the tissue sample into fluid contact with the solution in the second chamber. . Alternatively, the reagent can be placed in the first chamber with the second chamber empty, so that the tissue sample can be initially placed in the first chamber containing the reagent, After contacting the sample with the reagent for a desired period of time, the tissue sample is transferred to an empty second chamber for storage and further analysis.

  In another embodiment of the invention, the first chamber contains a first solution or reagent such as a tissue fixing solution, and the second chamber contains a second solution or reagent such as a nucleic acid stabilization solution. Store and place the tissue sample in the first chamber in fluid contact with the first solution for a desired period of time, then transfer the tissue sample to the second chamber and place the tissue sample in the second chamber. It can be contacted with the solution in the chamber. The embodiments described herein represent containers that can be used in any of these methods.

  Referring to the drawings wherein like reference characters refer to the same parts throughout the several views, FIGS. 1-3 generally illustrate a container 1 for storage of biological tissue samples. The container 1 has a first end at the container bottom 2, a second end at the container top 3, and an outer sidewall that extends between the container top 3 and the container bottom 2 and defines a container interior 5 4 is generally provided. The container interior 5 includes a first chamber 6 having a first chamber interior and a second chamber 7 having a second chamber interior, and is accommodated in the container 1. In one embodiment as shown in FIG. 1, the container 1 has a square shape with curved finger-like accommodations disposed on opposite sides of the container 1. It is also contemplated herein that the container 1 can be formed as any shape consistent with the intended use of the description herein.

  For example, in an alternative embodiment shown in FIGS. 9-10, the exterior of the container 1 can be provided with at least one, preferably a pair of flat sides 29, which can be easily gripped by the user. Or a surface on which a label can be applied is formed, and the flat sides make it easier to write on the label. The container 1 can be made of any known material, such as glass or plastic, and is desirably molded from a polymeric material. The container bottom 2 is preferably flat, so that the container 1 can be placed upright on a surface such as a table or lab bench. Alternatively, however, the container bottom 2 can take other shapes, for example a conical shape so as to be accommodated in the corresponding holding device. The container top 3 is also preferably flat, but can take other shapes.

  Referring again to FIGS. 1-3, the container interior 5 includes at least two chambers such as a first chamber 6 and a second chamber 7. The first chamber 6 and the second chamber 7 have a hollow cavity defined by a closed end 8, an open end 9 and a chamber sidewall 10 extending from the closed end 8 to the open end 9. In one embodiment, the first chamber 6 and the second chamber 7 have a substantially rectangular cross section extending over the entire length of the cavity, but the first chamber 6 and the second chamber 7 are It is also contemplated that other cross-sectional shapes, such as round or square, may be used. As described in further detail herein, each of the first chamber 6 and the second chamber 7 accommodates the same sample holder 11 shown in FIGS. 2 and 4A-4B therein, It has dimensions that can be accepted. Further, the overall size of the first chamber 6 and the second chamber 7 is changed to match the expected volume size of the sample holder 11 accommodated in the first chamber 6 and the second chamber 7. be able to.

  In one embodiment, as shown in FIG. 3, at least a portion of the chamber sidewall 10 is such that the closed ends 8 of the first chamber 6 and the second chamber 7 are integral with the container bottom 2 and It extends to the container bottom 2 so as to form a part of the container bottom 2. Alternatively, the closed ends 8 of the first chamber 6 and the second chamber 7 may be independent of the container bottom 2, in which case the chamber sidewall 10 does not extend to the container bottom 2. Referring again to FIG. 3, the open ends 9 of the first chamber 6 and the second chamber 7 are shielded so that the user can access the first chamber 6 and the second chamber 7 through the open end 9. It is not done. In one embodiment, the chamber sidewall 10 extends to the outer sidewall 4 of the container 1 such that the chamber sidewall 10 forms part of the container sidewall 4. In this embodiment, the chamber sidewalls 10 of the first chamber 6 and the second chamber 7 are joined to form the outer container sidewall 4. The upper surface of the container 1 forms a planar surface, with the open ends 9 of the first chamber 6 and the second chamber 7 extending over the surface. For example, as shown in FIG. 3, the upper end portion 10 a of the chamber side wall 10 is separated from the outer container side wall 4, and the planar surface 12 is a container side wall adjacent to the upper end portion 10 a of the chamber side wall 10 and the container top 3. It extends between four.

  The first chamber 6 and the second chamber 7 are provided in the container 1 so as to be fluidly insulated from each other. For example, the barrier 13 can be disposed between the first chamber 6 and the second chamber 7. The barrier 13 is configured such that the chamber side wall 10 forms a common side wall between the first chamber 6 and the second chamber 7 or a wall structure in which the first chamber 6 and the second chamber 7 are independent. It can be formed between the first chamber 6 and the second chamber 7 by making it have different chambers. By fluidly isolating the first chamber 6 and the second chamber 7, the user can place different liquids or solutions into each of the chambers without inadvertently mixing the liquids or solutions. it can. The first chamber 6 and the second chamber 7 can be formed from any known material, but preferably the first chamber 6 and the second chamber 7 are integrally formed from the same material as the container 1. Is done.

  In one embodiment, the first chamber 6 and the second chamber 7 can be disposed in the container 1 in a substantially parallel orientation relative to each other. This orientation is such that the longitudinal axis of the first chamber 6 represented by the straight line AA is parallel to the longitudinal axis of the second chamber 7 represented by the straight line BB. It is represented in the figure. With respect to the positioning of the first chamber 6 and the second chamber 7 within the container 1, in the embodiment shown in FIG. 6, the container 1 has a central longitudinal axis indicated by the line CC. And the first chamber 6 is generally disposed on a first side of a plane cutting the axis C-C, and the second chamber 7 is a second of the same plane cutting the axis C-C. 2 are disposed entirely on the opposite side. It is also contemplated herein that the first chamber 6 and the second chamber 7 can be disposed on the same side of the plane that cuts the longitudinal axis CC of the container 1.

  In one embodiment, shown in FIGS. 2 and 5, the container 1 is for surrounding at least one of the open ends 9 of at least one of the first chamber 6 and the second chamber 7. A cover or closure is also provided. The container 1 can be provided with a clear closure 14 that forms a cap or lid, preferably made of a molded polymer material that mates with the container top 3. The closure 14 can engage the container 1 at the container upper end 3, and one or more of the open ends 9 are oriented adjacent to the container upper end 3. The closure 14 can engage the container 1 in a manner such as a friction fit, snap fit, interlocking structural engagement, or otherwise, to form a fluid tight seal. Desirably, closure 14 and container 1 are provided with corresponding threads so that closure 14 can be screwed into container 1 to form a fluid tight seal therebetween. For example, the closure 14 as shown in FIG. 5 is located near the first threaded member 16 and the container top 3 disposed within the closure 14 as shown in FIG. The second threading member 17 disposed on the outside of the container 1 can be used so that the container 1 can be screwed together. Alternatively, such corresponding threads can be provided around the outer surface of the closure 14 and within the inner surface of the side wall 4 of the container 1 near the container top 3.

  In other embodiments, the closure or cover is removed, such as a foil or wax-like substance, attached to the upper end 3 of the container 1 so as to surround the open ends 9 of the first chamber 6 and the second chamber 7. Possible or pierceable membranes. A single membrane can surround the open ends 9 of both the first chamber 6 and the second chamber 7 in the container 1, or alternatively multiple membranes can be used, In turn, each membrane surrounds a separate open end 9 of the first chamber 6 and the second chamber 7, respectively. The membrane can be removed by the user when it is desirable to have access to a particular first chamber 6 and / or second chamber 7.

  A removable membrane 30 can be provided on one or both of the open ends 9 of the first chamber 6 and the second chamber 7 as shown in FIGS. For example, as shown in the embodiment of FIG. 9, a removable membrane in the form of a peelable cover 30, such as a foil or label, may be provided on one of the chambers such as the second chamber 7. it can.

  In this way, the interior of the first chamber 6 and / or the second chamber 7 can be maintained in a sterile or non-contaminated state during storage prior to use. A peelable cover 30 such as a foil or label can be removed from either the first chamber 6 and / or the second chamber 7 immediately before use. With such a foil, the first chamber 6 and the second chamber 7 can also be distinguished.

  Referring again to FIG. 2, the container 1 is intended to be used in conjunction with the sample holder 11 to test, store, or treat a biological tissue sample stored in the sample holder 11. . Any suitable sample holder 11 that can hold a biological tissue sample can be used with the container 1. The sample holder 11 is configured to be accommodated in the first chamber 6 of the container 1 and is configured to be subsequently accommodated in the second chamber 7. The sample holder 11 can form part of the closure 14 or can be provided separately for use with the container 1. The sample holder 11 shall be in the form of a conventional tissue cassette (“hist cassette”) as is known in the art for storing biological tissue samples when preparing samples for diagnostic tests. be able to. Such sample holders or histo cassettes are known for storing biological specimens when the specimens are prepared and processed with fluids for later analysis. Typically, such sample holders or histo cassettes are generally rectangular planar housing structures with internal cavities and are provided with a plurality of openings through the wall surface to allow fluid to flow through the housing. . In many cases, a removable or releasable cover surrounds the structure, such as through a hinge that is positioned along one end of the housing structure to provide a door-like cover to the housing structure. Also, a planar surface, which may be inclined, is often provided in such sample holders or histo cassettes, which serves as a labeling or writing surface. For example, the dimensions of such a sample holder are approximately 0.3 inches (0.76 cm) (± 0.1 inches (0.25 cm)) high, approximately 1.73 inches (4.39 cm) (± A length of 0.1 inches (0.25 cm)) and a width of about 1.12 inches (2.85 cm) (± 0.1 inches (0.25 cm)). Examples of sample holders that may be useful herein are shown in Beall et al., US Pat.

  For example, as shown in FIGS. 4A and 4B, the sample holder 11 includes a generally rectangular planar housing 23 having opposing walls that define an internal cavity 24 for holding a biological tissue sample therein. Is provided. At least one of the walls of the housing 23 may be an inclined wall, such as an inclined wall 22, which forms a surface for applying or writing a label, suitably housed in the sample holder 11. It forms a mechanism for identifying the sample. The housing 23 of the sample holder 11 is a closable structure and can include a door-like structure 20 connected by a hinge attached to the housing 23, thereby accessing the internal cavity 24. A tissue sample can be stored in or removed from the internal cavity 24. The door-like structure 20 may be formed integrally with the housing 23 so as to form a one-piece structure in which the door 20 is connected to the housing 23 through a flap and to have a mechanism for pivoting the door 20 with respect to the housing 23. Or the door 20 can be connected to the housing 23 in some other way, such as through a pivot point 21 that acts as a hinge to open the door 20 and access the internal cavity 24 from one side of the housing 23 It is good also as what is. The housing 23 of the sample holder 11 comprises at least one and preferably a plurality of fluid openings 25 configured to allow fluid to flow therethrough. In this method, when the housing 23 is positioned in the first chamber 6, the fluid in the first chamber 6 flows through the opening 25 and is stored in the internal cavity 24. Can contact with.

  The sample holder 11 can be formed as a separate element for use in the first chamber 6 or can be interconnected with a portion of the container 1. One aspect of the container 1 relates to limiting the amount of contact a user has between the biological tissue sample and the sample holder 11 to avoid sample contamination. In order to limit such contact, the container 1 is appropriately provided with a structure for fitting the sample holder 11 to the closing portion 14, whereby the sample is directly contacted only by the user with the closing portion 14. The cage 11 can be transferred between the first chamber 6 and the second chamber 7. Desirably, the sample holder 11 is fitted with the closing portion 14. Such a fit can be achieved by forming the sample holder 11 connected to the closure 14 or as an integral part formed with the closure 14, or the sample holder 11 can be It may be a separate structure that is removably matable with the closure 14 or is detachably connected.

  As shown in FIGS. 2 and 5, the closure 14 includes a frame or rack element that defines a receiving member 26 extending from the bottom surface of the closure 14 for receiving the sample holder 11 therein. be able to. The receiving member 26 may comprise a structure for maintaining the sample holder 11 attached to the closure 14 as shown in FIG. May be releasable from the receiving member 26. In particular, the receiving member 26 can comprise a structure that defines a rectangular recess for receiving the general size and shape of the sample holder 11. The receiving member 26 comprises at least one confinement latch or finger 27 extending therefrom, and the confinement latch or finger 27 engages the edge of the sample holder 11 and thereby accommodates the sample holder 11. It can be maintained in a recess defined by member 26. Such a finger-shaped portion 27 can be deflectable, whereby the edge of the sample holder 11 abuts against the corresponding wall surface of the storage member 26 and is held in place, and the sample holder 11 is held in the storage member. When pushed into the recess 26, the finger 27 deflects from the wall of the sample holder 11 and then returns at least partially towards the initial position, which causes the sample holder 11 to snap. Fits in place in the ceremony. The finger 27 is preferably deflectable so that the sample holder 11 can be removed from the receiving member 26 when necessary.

  The accommodating member 26 may have a general shape that allows the door 20 of the sample holder 11 to be opened while the housing 23 of the sample holder 11 is accommodated therein. In contrast, it is further contemplated that the internal cavity 24 of the sample holder 11 can be accessed while being held in place within the receiving member 26. For example, the receiving member 26 can have a wall cutout 50 for receiving the handle-like protrusion 28 of the door 20, and the overall dimensions and height of the wall of the receiving member 26 contact the handle 28, The door 20 can be designed to be opened manually by pivoting the door 20 on the receiving member 26 without interference. The storage member 26 can include a plurality of holes 38 for allowing fluid to pass through the storage member 26 to contact the sample holder 11 and the sample stored therein.

  The receiving member may comprise a structure that allows it to accept different sizes and shapes of histo cassettes or sample holders. The receiving member 26 can define a frame structure having a general arrangement with a plurality of confinement surfaces for receiving and supporting the sample holder. For example, as shown in one embodiment shown in FIGS. 15A-15E, the receiving member 26a can define a frame and can be applied to the wall surface of various sizes of sample holders. Cantilevered fingers 40a and 42a can be provided that function as compressible elements for pressure contact. Such finger-like portions 40a and 42a can be deflected from a low stress state to a high stress state, that is, a biasing force is applied to the wall surface of the sample holder arranged in the storage member 26a, and the storage member It can act as a biasing element or leaf spring to bias the sample holder so that it is pressed against the side wall of 26a to hold the sample holder in place. More specifically, the finger portion 40a applies a bias force to the sample holder housed in the housing member 26a, while the opposing surface 41a holds the end portion of the sample holder inside. The finger 27a holds another edge of the sample holder inside. The finger-like portion 42a applies a biasing force to the sample holder, while the opposing finger-like portion 27a holds the end portion of the sample holder in place. Such opposing, equal forces help maintain sample holders of various sizes and shapes in place. Further, as described above, a wall cutout portion 50a can be provided to receive the handle portion of the sample holder door, but this time, if necessary, while the sample holder is in place in the receiving member. The handle portion can also be accessed to open the door. In this way, the container 1 can comprise a single receiving member that can receive various sizes and shapes of histo cassettes for use with the container 1. In addition, the receiving member 26a can include a plurality of holes 38a for allowing fluid to flow through, as described above. Such a hole 38a allows the flow of fluid through the platform to the sample holder and the sample contained in the sample holder regardless of the size, shape, and / or geometry of the sample holder. It can have a pattern or orientation that provides sufficient flow for contact.

  Referring again to FIGS. 2 and 5, it can be seen that the containment element 26 can be attached to the bottom surface of the closure 14 through the platform 31. The platform 31 is rotatable with respect to the closure 14 such as via a knob extending from the platform 31 to the closure 14 to pivot the engagement between them, or via a pivot connection 32 or the like. It can attach to the closure part 14 as follows. In one embodiment, the sample holder 11 can be attached to the platform 31 either directly or through a receiving member 26 connected to the platform 31, thereby also allowing the sample holder 11 to rotate with respect to the closure 14. be able to. The housing member 26 can be appropriately connected to the home 31 using any mechanism such as an integrally formed structure, a mechanical connection part that forms a snap fit, an adhesive bond, and the like. In the embodiment of FIGS. 15A-15E, the receiving member 26a includes a protrusion at the knob 44a that can be received in a corresponding opening extending into the platform, thereby allowing the receiving member 26a within the platform. Can be maintained in a mechanically engaged state, and the platform 31 extends laterally of the receiving member 26a. By this method, the platform 31 is housed in the housing member 26 and the first position where the supported sample holder extends into the first chamber 6 of the container 1, and the sample holder is the container. The second position is such that it extends into one second chamber 7 and is configured to engage the container 1 at the upper end of the container 1.

  As shown in FIG. 5, the receiving member 26 can be connected to the platform 31 in a position and manner that is offset from the main central axis DD of the closure 14. With such an offset orientation, in some cases, within each first chamber 6 and second chamber 7 of the container 1, regardless of the orientation of the closure with respect to the first chamber 6 and the second chamber 7. The sample holder 11 is properly aligned. In particular, the first chamber 6 and the second chamber 7 are aligned in the container 1 about the central axis CC of the container 1 as shown in FIG. By placing the storage member 26 in a position relative to the platform 31 that is offset from the central axis C-C, the sample holder 11 is properly stored in the storage member 26 and the closure 1 is above the top of the container 1. It can be placed in either the first chamber 6 or the second chamber 7 of the container 1 in an appropriate orientation. When the sample holder 11 is inserted into either the first chamber 6 or the second chamber 7 with a rotatable connection between the platform 31 and the closure 14, the receiving member 26 and / or Alternatively, one or both of the sample holders 11 lightly contacts the side wall 10 of the chamber after rotation of the closure 14 so that the sample holder 11 rotates relative to the closure 14 and the closure 14 is in the container 1 And can be engaged with each other. Thereby, the amount of stirring performed on the sample stored in the sample holder 11 when the closing portion 14 and the housing 1 are engaged can be greatly reduced.

  As shown in FIGS. 16A-16B, the platform 31 may serve to form a fluid tight seal of the closure 14 with respect to the container 1. The platform 31 can be fabricated from a material configured to sealingly engage the surface 12 at the container top 3 when the closure 14 is fitted within the container 1. For example, at least the bottom surface of the platform 31 can be made of an elastic material, which is the plane of the container 1 shown in FIG. 2 when the closure 14 is engaged with and engaged with the container 1. The sealing surface 15 is formed so as to be fitted to at least a part of the surface 12. Since the closure 14 receives torque when engaged with the container 1, the sealing surface 15 is sealingly engaged with the planar surface 12 to form a fluid tight seal. Desirably, as can be seen from the cross-section of FIG. 16A, the platform 31 uses a two-time molding material and the sealing surface 15 is molded of an elastic material to provide sealing properties when engaged with the container 1 and facing The surface 12a is formed of a polymer material so as to be connected to the receiving member 26. In another embodiment, as shown in FIGS. 16A-16B, the sealing surface 15 is provided on the open end of the first chamber of the container 1 (as already described) and / or the second Engageable with the circumference of the open end of the chamber and forms a liquid impermeable seal when the closure 14 is engaged with the container 1. Optionally, the sealing surface 15 can be made of rubberized or some other form of deflectable material, which makes it easier to form a seal with the container 1.

  More specifically, in the embodiment depicted in FIG. 16B, two separate sealing surfaces 15, 15 for sealing engagement around the open ends of the first chamber and the second chamber, respectively. 'Equipped with. Seal surfaces 15, 15 'provide first and second perimeter seals for forming fluid tight engagement with the open ends of these chambers. Further, the accommodating member 26a extends from the surface of the platform 31 to a position within the circumference of the sealing surface 15 '. In this way, when the sample holder is supported by the receiving member 26a and positioned in one of the first chamber or the second chamber, the seal surface 15 'is a chamber that houses the receiving member 26a. The other sealing surface 15 is sealed on the circumference of the open end of the other chamber that does not accommodate the accommodating member 26a. Thus, the sealing surfaces 15, 15 'form a liquid impermeable seal with the first chamber and the second chamber, respectively. Furthermore, the sealing surfaces 15, 15 'have the same structure and are therefore configured to seal either the first chamber or the second chamber. In this regard, when the receiving member 26a is transferred from one chamber to the other in use, the sealing surfaces 15, 15 'are disengaged from the first chamber and then the other chamber is removed. It is comprised so that it may seal.

  In another embodiment, the platform may comprise other sealing elements configured to function as a seal against the top of the container 1. For example, as shown in FIGS. 19A-19C, the platform 31a can include a peripheral seal 33a that extends around the circumference of the platform 31a. The peripheral seal 33a extends so as to sealingly engage with the rim 5a that extends on the circumference of the container 1 when the closing portion 14 is fitted to the container 1, that is, extends on the circumference of the top surface of the container. It is configured. The perimeter seal 33a can be an independent element connected to the circumference of the platform 31a or attached by some other means, or can be integrally formed or co-molded. The perimeter seal 33a is made of a material that can form a sealing surface against the rim 5a when the closure 14 is mated with the container 1. Desirably, the perimeter seal 33a is made of a material configured to bend and / or deflect as it moves relative to the rim 5a and desirably has sufficient flexibility to form a perimeter seal. On the other hand, it is integrally formed with the platform 31a with a material having sufficient structural robustness to support the platform. In this manner, when the closure 14 is mated with the container 1, the peripheral seal 33a engages the rim 5a to form a fluid tight seal. When the closure 14 is mated with the container 1, the peripheral seal 33 a forms an effective seal with the top of the container 1 at the rim 5 a and an effective sealing property between the closure 14 and the container 1. , Thereby preventing fluid from leaking out of the closure 14 of the container 1. Furthermore, the peripheral seal 33a functions as the only independent seal of the closure 14, as described above, or engages around the open end of the first chamber and / or the open end of the second chamber. It can work as a secondary seal in combination with the sealing surface 15a.

  With reference to FIGS. 11A-11B and FIGS. 17-18, the container 1 may also be provided with features for distinguishing between the first chamber 6 and the second chamber 7, such as a visual indicator 53. Recognize. The visual marker 53 can be disposed at any position on the container 1 that is visible to the user. Such indicia can be arranged on the container side wall 4. In other embodiments, the sign can be disposed on one or more container sidewalls. For example, the visual indicator 53 can be in the form of alphanumeric symbols, straight lines, or a series of straight lines, color discrimination, different surface finishes, and the like. The visual marker 53 can be integrated into the membrane covering a specific open end of the first chamber 6 and / or the second chamber 7.

  Alternatively, as shown in FIGS. 17-18, the visual indicator 53 is physically disposed at a position where the first numerical indicator 55 is adjacent to the first chamber 6, and the second numerical indicator 55 is provided. 56 can comprise a label 54 disposed around a portion of the container sidewall 4 that is physically disposed at a location adjacent to the second chamber 7. In one configuration, the same label 54 can include both a first numeric indicator 55 and a second numeric indicator 56. In other configurations, a portion of the container 1, such as a flat portion of the container side wall 4, includes a labeling surface so that the first numeric indicator 55 and the second numeric indicator 56 of the label 54 can be It can be determined whether it is properly aligned.

  In other embodiments, as shown in FIGS. 11A and 11B, the visual markings 53 are on the container top 3 near the open ends 9 of the first chamber 6 and the second chamber 7, respectively. It is arranged. In particular, a visual indicator 53 such as the number “1” (eg, specifying the first step of the procedure) is used to identify the first chamber 6 and a visual indicator 53 such as the number “2”. (E.g., specifying the second step of the procedure) can be used to identify the second chamber 7. As shown in FIG. 11A, the first visual indicator 53 “1” is a positive projection that forms a knob that is clearly visible to the user when the closure 14 is removed from the container 1 for initial use. The second visual indicator 53 “2” can be a reverse concavity, which is partially obstructed by a peelable cover 30 such as a foil or label. Furthermore, the part of the container 1 comprising the first chamber 6 may be varied and / or such as a surface covered with frost to distinguish the first chamber 6 from the second chamber 7. It can also include a surface finish with a visually recognizable appearance. Such a distinction makes it clear to the user which part of the container 10 is to be used first.

  Alternatively, as shown in FIGS. 12A-12B, the visual indicator 53 can include a distinguishing element molded within the container geometry. The exact arrangement of such visual markers can take a variety of forms. For example, the container 1 may include a rib 33a extending toward the first chamber 6 and a different rib 33b extending toward the second chamber 7 in a direction different from the rib 33a. Optionally, the first group of ribs 33a is disposed at a position adjacent to the first chamber 6 having an orientation substantially perpendicular to the sidewalls of the first chamber 6, and the second group of ribs 33b. Can be disposed at a position adjacent to the second chamber 7 having a substantially parallel orientation with respect to the side wall of the second chamber 7. Alternatively, the first group of ribs 33a is disposed at a position adjacent to the first chamber 6 having an orientation substantially parallel to the side wall of the first chamber 6, and the second group of ribs 33b. Can be disposed at a position adjacent to the second chamber 7 having a substantially vertical orientation with respect to the side wall of the second chamber 7. In yet another configuration, one of the first group of ribs 33a or the second group of ribs 33b is at an angle with respect to the side wall of one of the first chamber 6 and the second chamber 7. Different angles of the first group of ribs 33a and the second group of ribs 33b with respect to the other side walls of the first chamber 6 and the second chamber 7; Can be arranged. In yet another configuration, one of the first group of ribs 33a and the second group of ribs 33b is at an angle with respect to one sidewall of the first chamber 6 and the second chamber 7. And the other of the first group of ribs 33a and the second group of ribs 33b is substantially parallel to the other side wall of the first chamber 6 and the second chamber 7. It is arranged in an orientation or a substantially vertical orientation. Such a different orientation of the ribs provides such a visual indicator 53 that clearly shows the distinction between the first chamber 6 and the second chamber 7. The exact arrangement of the rib orientation can take a variety of forms and arrangements. Optionally, the visual marker 53 may comprise a removable membrane on one or both of the first chamber 6 and the second chamber 7. In other embodiments, the visual markings 53 can include forming the first chamber 6 from a first colored material and forming the second chamber 7 from a different colored material.

  Referring to FIG. 8, it can be seen that the container 1 can be assembled and a liquid such as a solution or reagent can be placed in the first chamber 6 and / or the second chamber 7 during manufacture. Alternatively, such a liquid may be filled into the first chamber 6 and / or the second chamber 7 at any time before use, such as immediately before the tissue sample is inserted into the sample holder 11.

  The container 1 can also be configured for use with a one reagent system. In this way, a single reagent solution such as a tissue fixative such as formalin can be placed in the second chamber 7. Such a fixative stabilizes the RNA in the tissue sample and uses this to perform a molecular diagnostic test. Alternatively, the container 1 can be configured for use with a two solution or two reagent system. For example, the cleaning solution can be put into the second chamber 7 to dilute the first reagent fixing agent in the first chamber 6. It is possible to put the same reagent in the first chamber 6 and the second chamber 7, but it is convenient to transfer a biological sample from one reagent to a fresh constant amount of the same reagent after a certain period of time. This is because it may be good. Alternatively, a first reagent solution such as a tissue fixing agent such as formalin is used in the first chamber 6 and a second stabilizer such as a stabilizer in the form of a nucleic acid stabilizing reagent for stabilizing the morphology of the tissue sample. The reagent solution can be placed in the second chamber 7.

  Any reagent can be used in the containers herein. For example, fixatives include formalin, ethanol solution, Carnoy's solution I (ethanol and acetic acid), Carnoy's solution II (ethanol, chloroform, and acetic acid), metacarn (methanol, chloroform, and acetic acid), Clark fixative, Boonfix, and the like Can be. A non-limiting list of commercially available fixatives includes, but is not limited to, MIRSKY'S FIXATIVE (commercially available from National Diagnostics, Inc., Atlanta, GA), GLYOFIX (Shandon Lipshaw, Pittsburgh, PA). HISTOCHOICE (commercially available from Amresco), HISTOX (commercially available from Trend Scientific, New Brighton, Minnesota), KRYOFIX (commercially available from Merck) MICROFIX (commercially available from Energy Beam Sciences, Inc., East Granby, Conn.), NEOFIX (Me (commercially available from ck), NOTOX (commercially available from Earth Safe Industries, Inc., Bellmead, NJ), OMNIFIX II and OMNIFIX 2000 (commercially available from AnCon Genetics, Inc., Melville, NY). PREFER (commercially available from Anatech Ltd., Battle Creek, Michigan), PRESERVE (commercially available from Energy Beam Sciences, Inc., East Granby, Conn.), SAFEFIX II (Thermo Fischer Fischer Fischer Fischer Fischer Fischer). STATFIX (StatLa, Louisville, Tex.). Medical Products, Inc.), STF (Stretch Tissue Fixative, commercially available from Streck Laboratories, Inc., Omaha, Nebraska), UMFIX (Sakura Finetec, Inc., available from Sakura, USA, Inc., Torrance, Calif.). FINEFIX (commercially available from Milestone Medical, Shelton, Conn.). Commercial stabilizers include, but are not limited to, RNALATER (commercially available from Ambion, Inc., Austin, Texas) and RNESY (commercially available from Qiagen, Inc., Valencia, Calif.). Can be mentioned. Other reagents known or later discovered for use as fixatives and / or stabilizers are intended to be useful in the present invention.

  In one embodiment, the second chamber 7 of the container 1 is filled with the desired liquid and can be arranged to adhere a peelable cover 30 as shown in FIG. From this point onwards, the first chamber 6 can be filled with different liquid media (eg in embodiments with a two-reagent system). The closure 14 is placed over the container top 3 when the sample holder 11 extends or does not extend therefrom, as shown in FIG. To be screwed together. The container 1 assembled in this way can be packaged as a separate package and stored until use if necessary.

  Referring again to FIG. 8, in use, a biological sample, such as a tissue sample taken from a patient for molecular or tissue diagnostic testing, is placed in a cavity 24 (shown in FIG. 4A) in the sample holder 11. . In embodiments where the sample holder 11 is provided as a separate element, the closure 14 can be removed from the container 1 and the sample holder 11 can then be inserted into the receiving member 26 of the closure 14. Alternatively, if the sample holder 11 is provided with a closure 14, either after the closure 14 has been removed from the container 1 with the sample holder 11 connected or by removing and then reattaching the sample holder 11. A tissue sample can be placed in the sample holder 11.

  The closing part 14 in which the sample holder 11 stores the tissue sample is subsequently placed on the container top 3 and the sample holder 11 is located in the first chamber 6 as shown in FIG. Are arranged in the first chamber 6. The closure 14 is then mated with the container 1, such as by rotating and screwing the closure 14 and / or container housing relative to each other. In each such rotation, since the first chamber 6 is sized and oriented to accept a particular shape of the sample holder 11, the sample holder 11 is oriented in the first chamber 6. Can be maintained. When torque is applied to the closure 14 and lowered to the container 1, the sealing surface 15 engages the surface 12 of the container 1 and forms a fluid tight seal.

  In an embodiment comprising a single reagent system as described above, the tissue sample is now stored in the sample holder 11 in the first chamber 6 that is insulated from the reagent in the second chamber 7 at this point. Yes. If it is desired to bring the tissue sample into contact with the reagent, the user removes the closure 14 from the container 1 and thus removes the sample holder 11 from the first chamber 6. Then, if a peelable cover 30 such as a foil or label is used, it is removed to expose the second chamber 7 and then the sample holder 11 is moved to the second as shown in FIG. Can be inserted into two chambers 7. The sample holder 11 can be transferred from the first chamber 6 to the second chamber 7 in a state where the sample holder 11 is attached to the closing portion 14 of the container 1. The sample holder 11 after being attached to 14 is not touched directly, thus avoiding contamination of the biological sample. In addition, by maintaining the tissue sample fluidly isolated from the fluid or reagent contained in the second chamber 7, the contact between the sample and the fluid is precisely adjusted until the desired time is reached. be able to. In addition, the length of time that the tissue sample contacts the fluid or reagent can also be accurately adjusted and monitored.

  Referring to FIG. 8 again, in the embodiment including the two-reagent system as described above, when the sample holder 11 is placed in the first chamber 6, the tissue sample is stored in the first chamber 6. In contact with the first reagent, and such reagent flows through the fluid opening 25 of the sample holder 11 and thereby is contained within the internal cavity 24 (shown in FIG. 4A). Contact with tissue sample. The tissue sample can remain in contact with the fluid or reagent in the first chamber 6 for a specified period of time, after which the closure 14 is removed and as described above with respect to FIG. The sample holder 11 can be repositioned so that it enters the second chamber 7. In this way, the second fluid or reagent maintained in the second chamber 7 can come into contact with the tissue sample stored in the sample holder 11. After contact with the second fluid or reagent for a desired period of time, the closure 14 can be removed and the tissue sample removed from the sample holder 11 for the desired diagnostic test.

  Since the sample holder 11 is connected to the closing part 14, access to the tissue sample stored in the sample holder 11 is reversed by removing the closing part 14 from the container 1 and placing the outer surface on the counter. It can be done in a way that prevents the sample holder 11 from being exposed. The fluid stored in the sample holder 11 drops downward in the bottom surface or the inner surface of the closing portion 14 and is captured by the rim surrounding the closing portion 14, thereby leaking or spilling on the counter surface. Can be prevented. The sample holder 11 may be openable while the closure 14 and the sample holder 11 are connected, thereby allowing easy access to the tissue sample contained therein. In addition, the sample holder 11 can be properly supported to be held in place without having to physically contact a portion of the sample holder to hold it in place while accessing the sample and is therefore used. It is possible to eliminate the possibility of sample contamination caused by contact with a person. After this, the container 1 can be cleaned and reused, or more preferably discarded to prevent cross-contamination with other samples.

  Referring now to FIG. 13, an alternative embodiment of the container is shown. In this embodiment, the container 101 comprises a first chamber 106 and a second chamber 107, wherein each chamber has an open top end 109, closed bottom ends 108a-b, and open end 109 and closed end. A sidewall 110 extending between 108a-b. The first chamber 106 and the second chamber 107 are arranged such that the bottom end of the first chamber 108a is directly adjacent to or in contact with the bottom end of the second chamber 108b. In this arrangement, the bottom end of the first chamber 108a is joined along the common plane Z with the bottom end of the second container 108b. The bottom end of the first chamber 108a is thus integrated with the bottom end of the second chamber 108b. The first chamber 106 and the second chamber 107 have dimensions such that the same sample holder 11 can be disposed therein. A closing portion 114 is coupled to the first chamber 106 so as to surround the open end 109. The closure 114 can engage the open ends 109 of the first chamber 106 and the second chamber 107 in a mutually exclusive manner. The closure 114 in this embodiment is consistent with the closure 114 disclosed above in connection with other embodiments.

  Referring now to FIG. 14, another alternative embodiment of the container is shown. In this embodiment, the container 201 comprises a first chamber 206 and a second chamber 207, each chamber having an open top end 209a-b, a closed bottom end 208, and an open end 209a-b and a closed end 208. Having sidewalls 210 extending therebetween. The first chamber 206 and the second chamber 207 have dimensions such that the same sample holder 11 can be disposed therein. The first chamber 206 and the second chamber 207 are disposed such that the closing portion 214 is disposed between the first chamber 206 and the second chamber 207. The closure 214 can be mated with the first chamber 206 at the open upper end 209a in a manner such as a friction fit, snap fit, threadable engagement, interlocking structural engagement, or the like. Also, it can be fitted with the second chamber 207 at the open upper end 209b, thereby forming a liquid tight seal.

  While embodiments of the invention may be satisfied in many different forms, it is to be understood that the present disclosure is an example of the principles of the invention, as illustrated in the drawings and described in detail herein. Are specific embodiments of the present invention with the understanding that they are not intended to be limited to the illustrated embodiments. Various other embodiments will be apparent to and readily manufactured by those skilled in the art without departing from the scope and spirit of the invention. For example, although two chambers are described herein, it is contemplated that the containers described herein can include any number of chambers for housing various reagents therein. . The scope of the present invention is defined by the appended claims and their equivalents.

Claims (65)

A container assembly,
A container extending between a first end and a second end,
A first chamber having a side wall defining an interior of the first chamber extending between an open end and a closed end and configured to receive a sample holder;
A second chamber having a side wall defining an interior of a second chamber extending between an open end and a closed end and configured to subsequently receive the sample holder, the first chamber An interior and an interior of the second chamber are accessible through the first end of the container;
A closing portion engaging the first end of the container to surround at least one of the open end of the first chamber and the open end of the second chamber. Container assembly.   The closure is configured such that the closure engages the first end of the container and the sample holder is disposed within one of the first chamber and the second chamber. 2. The container assembly of claim 1, wherein when it is done, at least one of the open end of the first chamber and the open end of the second chamber is selectively sealed.   The container assembly according to claim 1, wherein the sample holder is detachably connected to the closing portion.   The container assembly according to claim 1, wherein the sample holder is rotatable with respect to the closure.   The container assembly of claim 1, wherein the closure further comprises a platform configured to receive the sample holder.   6. A container assembly according to claim 5, wherein the platform is rotatable with respect to the closure.   6. The container assembly according to claim 5, further comprising a receiving member configured to receive the sample holder, wherein the receiving member is connected to the platform.   The container assembly according to claim 5, wherein the sample holder is removably accommodated in the accommodating member.   The sample holder includes a closable housing that defines an internal cavity for holding a biological sample, the housing being disposed within at least one of the first chamber and the second chamber. The container assembly of claim 1, comprising a plurality of fluid openings configured to allow a fluid to enter the internal cavity.   The container assembly according to claim 1, wherein the sample holder is a tissue cassette.   The container assembly according to claim 1, wherein the closing portion and the container can be fitted so as to be screwed together.   The sample holder is moved in the vertical direction inside the first chamber and the second chamber by fitting the closing portion and the container so that they can be screwed together. The container assembly according to claim 11.   The closing portion is engageable with a circumference of at least one of the open end of the first chamber and the open end of the second chamber, and forms a liquid-impermeable seal by this engagement. The container assembly of claim 1, further comprising a seal.   The platform further includes a platform that is rotatably engaged with the closure, the platform being in engagement with the first chamber when the closure is engaged with the first end of the container. The container assembly according to claim 1, comprising a first seal for mating and a second seal for sealing engagement with the second chamber.   The first seal includes a peripheral seal that engages the circumference of the open end of the first chamber, and the second seal includes the circumference of the open end of the second first chamber. 15. A container assembly according to claim 14, including a peripheral seal that engages.   The platform further includes a receiving member configured to receive the sample holder, the receiving member being connected to the platform within one circumference of the first seal or the second seal. 16. A container assembly according to claim 15, wherein:   The container has a longitudinal axis, the first chamber is disposed on a first side of the longitudinal axis, and the second chamber is a second side opposite the longitudinal axis. The container assembly according to claim 1, wherein the container assembly is disposed on the container.   The container assembly of claim 1, wherein the sidewall of the first chamber and the sidewall of the second chamber are joined to define an outer sidewall of the container.   The container has a first end and a second end, and the closure engages the first end of the container, and the open end of the first chamber and the The container assembly of claim 1, surrounding the open end of a second chamber.   The container assembly of claim 1, further comprising a visual indicator for distinguishing the first chamber from the second chamber.   21. A container assembly according to claim 20, wherein the visual indicator is a label selectively positioned on an outer surface of the container.   21. A container assembly according to claim 20, wherein the visual indicator is formed together with a portion of the container.   23. The visual indicator is integrated with the container at a location adjacent to at least one of the open end of the first chamber and the open end of the second chamber. A container assembly as described in.   21. A container assembly according to claim 20, wherein the visual indicator is an alphanumeric representation.   The interior of the first chamber has a first intended fill volume, the interior of the second chamber has a second intended fill volume, and the second intended fill volume is The container assembly of claim 1, wherein the container assembly is different from the first intended fill volume.   A first fluid disposed within the first chamber; and a second fluid disposed within the second chamber, wherein the first fluid and the second fluid The container assembly according to claim 1, wherein the container assembly is different.   And further comprising a fluid disposed within the first chamber having a first concentration and a fluid disposed within the second chamber having a second concentration, wherein the first concentration is The container assembly according to claim 1, wherein the container assembly is different from the second concentration.   A membrane surrounding at least one of the open end of the first chamber and the open end of the second chamber, the member being at least partially removable or puncturable; The container assembly according to claim 1. A container assembly for storing a biological sample comprising:
A container comprising a first end, a second end, and a sidewall extending between the first end and the second end defining a container interior;
A first chamber defined within the container interior and having an opening adjacent to the first end of the container;
A second chamber fluidly insulated from the first chamber having an opening defined within the container interior and adjacent to the first end of the container;
A first holder in which the sample holder is received in the first chamber for sealing engagement with the first end of the container and for providing a sample holder for storing a biological sample therein. And a closure configured to engage the container in a second orientation in which the same sample holder is subsequently housed in the second chamber. A container assembly for storing samples.   30. The container assembly of claim 29, wherein the sample holder is rotatable with respect to the closure.   The sample holder includes a closeable housing defining an internal cavity for holding a biological sample, the housing being a fluid disposed in at least one of the first chamber and the second chamber. 30. The container assembly of claim 29, comprising a plurality of fluid openings configured to be placed within the internal cavity.   30. The container assembly of claim 29, wherein the sample holder is a tissue cassette.   The closing portion is engageable with at least one circumference of the opening portion of the first chamber and the opening portion of the second chamber, and forms a liquid-impermeable seal by this engagement. 30. The container assembly of claim 29, further comprising a seal.   30. The container assembly of claim 29, further comprising a visual indicator for distinguishing the first chamber from the second chamber.   35. A container assembly according to claim 34, wherein the visual indicator is a label selectively positioned on an outer surface of the container.   35. The container assembly of claim 34, wherein the visual indicator is formed with a portion of the container.   A first fluid disposed in the first chamber; and a second fluid disposed in the second chamber, wherein the first fluid is different from the second fluid. 30. The container assembly of claim 29.   And further including a fluid disposed in the first chamber having a first concentration and a fluid disposed in the second chamber having a second concentration, wherein the first concentration is the first concentration. 30. The container assembly of claim 29, wherein the container assembly is different from a concentration of two.   30. The container assembly of claim 29, further comprising a membrane surrounding at least one of the opening of the first chamber and the opening of the second chamber. A method for storing a biological sample,
A first chamber having a side wall extending between an open end and a closed end defining an interior of the first chamber in which the first fluid is disposed; a second fluid disposed in the first chamber A second chamber having a sidewall extending between an open end and a closed end defining an interior of the second chamber, wherein the first fluid is different from the second fluid and the second fluid Forming a container, wherein the interior of the chamber is fluidly insulated from the interior of the first chamber;
Inserting a sample holder into the first chamber interior;
And subsequently transferring the sample holder into the interior of the second chamber.   A closing portion to which the sample holder is detachably connected while the sample holder is disposed in at least one of the first chamber and the second chamber; 41. The method of claim 40, further comprising the step of threadably engaging a portion of the container. A method of assembling a container,
Forming a container, closure, receiving member, and platform, comprising:
The container extends between a first chamber having a side wall extending between an open end and a closed end defining a first chamber interior, and between an open end and a closed end defining a second chamber interior. Comprising a second chamber having a sidewall to:
Attaching the platform to the closure;
Aligning the receiving member with one of the first chamber or the second chamber;
Fitting the closure to the container. A method for assembling the container.   43. The method of claim 42, wherein the receiving member is formed with the platform.   44. The method of claim 43, further comprising connecting the receiving member to the platform.   43. The method of claim 42, wherein the receiving member is integral with the platform.   43. The method of claim 42, wherein the platform is movable to rotate with respect to the closure.   Fluidly sealing at least one of the open end of the first chamber and the open end of the second chamber from each other through fitting of the closure and the container. 43. The method of claim 42.   The platform is formed of a thermoplastic elastomer, the thermoplastic elastomer providing a sealing engagement between one or more of the first chamber and the second chamber. 48. The method according to 47. A support assembly for supporting a sample holder configured to receive a biological sample therein,
A housing having a frame configured to receive the sample holder therein, the frame including a structure for engaging the sample holder and supporting the sample holder in the frame. Members,
A platform connected to the housing member and supporting the housing member and configured to engage the container so that the sample holder housed in the housing member extends into the interior of the container. And a support assembly.   The platform is housed in the housing member at a first position such that the sample holder housed in the housing member extends into the first internal portion of the container. 50. The assembly of claim 49, wherein the sample holder is configured to engage the container at a second position such that the sample holder extends into the second interior portion of the container.   The assembly according to claim 49, wherein the receiving member receives the sample holder so as to be releasable.   50. The assembly of claim 49, wherein the receiving member comprises at least one finger that engages the sample holder to support the sample holder within the frame of the receiving member.   50. The finger is configured to apply a biasing force to the sample holder to maintain and support the sample holder within the frame of the receiving member. Assembly.   The accommodating member includes a plurality of fingers for engaging with the sample holder, and at least one of the fingers maintains and supports the sample holder with respect to the frame of the accommodating member. 53. The assembly of claim 52, wherein the assembly is configured to apply a biasing force to the sample holder.   55. The plurality of fingers are configured to maintain and support a plurality of sample holders of various sizes and shapes with respect to the frame of the receiving member. assembly.   50. The frame of claim 49, wherein the frame comprises at least one opening configured to allow fluid to flow through the frame and to contact the sample holder supported by the frame. Assembly.   50. The assembly of claim 49, wherein the platform extends laterally with respect to the receiving member.   50. A closure assembly for enclosing a container, wherein the platform comprises a support assembly according to claim 49, wherein the platform interconnects the receiving member to the closure assembly.   59. The closure assembly of claim 58, wherein the platform is rotatably supported on the closure assembly. A sample holder housing member,
A plurality of confinement surfaces capable of confining the tapered end of the sample holder and the non-tapered end of the sample holder;
At least one cantilevered finger extending from the frame and deflectable from a low stress state to a high stress state when a sample holder is engaged in the confinement surface, thereby A sample holder housing member comprising a generally planar frame comprising at least one cantilevered finger that maintains the sample holder within the frame of the housing member.   61. The sample holder of claim 60, wherein at least one of the confinement surfaces is a confinement latch, the confinement latch being deflectable to accept an edge of the sample holder.   62. The sample holder of claim 61, wherein the confinement latch can engage only the tapered end of the sample holder.   61. The sample holder according to claim 60, comprising a plurality of cantilever fingers extending from the frame. An assembly,
A sample holder, wherein the sample holder is a tissue cassette comprising a cavity that can be selectively surrounded by a door, the tissue cassette further comprising a tapered end and a non-tapered end. When,
A housing member for removably housing the sample holder, the housing member comprising at least one deflectable surface extending from a housing member base frame, wherein the at least one deflectable surface comprises: An assembly comprising: a receiving member that temporarily positions the sample holder with respect to the receiving member when the sample holder is positioned within the receiving member.   The assembly of claim 64, wherein the door of the sample holder is openable with respect to the cavity while the sample holder is positioned in the receiving member.